Active Not RecruitingPhase 1 / Phase 2NCT03899792

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

Checked against the public recordLast updated Jan 6, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations26
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Selpercatinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: * Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies * Evidence of an activating RET gene alteration in the tumor and/or blood * Measurable or non-measurable disease * Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50 * Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days * Adequate hematologic, hepatic and renal function. * Ability to receive study drug therapy orally or via gastric access * Willingness of men and women of reproductive potential to observe conventional and effective birth control Exclusion Criteria: * Major surgery within two weeks prior to planned start of LOXO-292 * Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 * Active uncontrolled systemic bacterial, viral, fungal or parasitic infection * Clinically significant active malabsorption syndrome * Pregnancy or lactation * Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) * Uncontrolled symptomatic hypercalcemia or hypocalcemia * Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension * Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor\[s\])

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Childrens Hospital of Los AngelesLos Angeles, California
  • The Children's Hospital for Cancer and Blood DisordersAurora, Colorado
  • Nemours Children's HealthOrlando, Florida
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • University of Minnesota HospitalMinneapolis, Minnesota
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
  • Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
  • St. Jude Children's Research HospitalMemphis, Tennessee
  • University of Texas Southwestern Medical Center at DallasDallas, Texas
  • Texas Childrens HospitalHouston, Texas
  • Seattle Children's Hospital Research FoundationSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2026. Always confirm current availability with the study team.

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